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Senate Passes 21st Century Cures Act

December 13, 2016

On December 13, 2016, President Barack Obama signed the 21st Century Cures Act, a $6.3 billion medical research bill.  The bill authorizes billions of dollars to the National Institutes of Health (“NIH”).  Many of the NIH authorized funds are slated for Alzheimer’s and cancer research, including Vice President Joe Biden’s Cancer Moonshot initiative.

Additionally, the bill pledges to provide the states with $1 billion in resources to fight the heroin and prescription opioid epidemic.[1]  The bill will also take steps to improve access to mental health care.

The Food and Drug Administration is expected to receive $500 million to streamline its regulatory structure, hire more employees, and speed up the review of drugs and devices.  The bill prioritizes the review of breakthrough devices “to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions.”[2]

The bill will also allow drug companies to promote off-label uses to insurance companies.

An earlier version of the bill that would have exempted medical device companies from reporting some speaker fees paid to physicians, provided for under the Physician Payments Sunshine Act section of the Affordable Care Act, was excised shortly before the House vote.[3]

Scott Whitaker, president and CEO of the Advanced Medical Technology Association stated that the passage of the 21st Century Cures Act “is a milestone in improving the innovation ecosystem for medical technology and ensuring the availability of new life-saving, life-enhancing devices and diagnostics for patients.”[4]

For more information about the 21st Century Cures Act, please contact Adam M. Masin at amasin@goodwin.com.

 

[1] Statement by the Press Secretary on H.R. 34, the 21st Century Cures Act, https://www.whitehouse.gov/the-press-office/2016/11/30/statement-press-secretary-hr-34-21st-century-cures-act (last visited Dec. 6, 2016).

[2] 21st Century Cures Act H.R.6, 114th Cong. § 2201 (2015).

[3]Jennifer Steinhauer & Sabrina Tavernis, House Overwhelmingly Approves Sweeping Health Measure, N.Y. Times, Dec. 6, 2016, http://www.nytimes.com/2016/11/30/us/politics/house-overwhelmingly-approves-sweeping-health-measure.html.

[4] AdvaMed Praises House Passage of 21st Century Cures Act, https://www.advamed.org/newsroom/press-releases/advamed-praises-house-passage-21st-century-cures-act (last visited Dec. 6, 2016).

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